In January 2015, Advera Health released a Drug Safety Monitor analysis comparing the safety of then newly approved Hepatitis C drugs Viekira Pak to Harvoni and Solvaldi (hereafter just Harvoni). Our analysts concluded,
…both Harvoni and Sovaldi appear to be safer options compared to Viekira Pak, but only close post-marketing monitoring will determine the true safety profile of these medications.”
We went on to write several blog posts asking questions about Express Scripts’, and other payers’ decisions to exclusively cover Viekira Pak. As well as participated in panel discussions put on separately by the American Journal of Managed Care (AJMC) and Bloomberg with other healthcare pundits to defend our position. And we received a lot of “fan mail” from Abbvie supporters.
Confident in our conclusion that Harvoni was the safer choice, we still reiterated our core belief that only with close post-marketing monitoring will the true safety profile of the drugs be ultimately revealed. And “close post-marketing monitoring” we did. Since January 2015, the Advera Health team has submitted 7 separate Freedom of Information Act (FOIA) requests for these three drugs, providing our clients with virtual real-time data, and over 11,000 case reports in these past 9 months, all of which were made available to our clients before FDA publicly released the data on its’ own.
And what did these post marketing results reveal? Viekira Pak unequivocally is less safe than Harvoni. On October 12, 2015, our analyst team issued a Drug Safety Monitor* (Advera Health’s subscription drug safety newsfeed) titled, New FOIA Data Reveal Viekira Pak Riskier than Harvoni, with the following conclusion,
“…Viekira Pak's RxCost per prescription increased by 200% to $151.00, and its RxScore increased by 8 points to 73.93, making it the riskiest option of the three drugs, according to our analysis. In contrast, our analysis points towards Harvoni, as the safest option, with a 32% drop in RxCost per prescription ($60.24), and the lowest RxScore (68.98) of the 3 chronic hepatitis C treatments discussed here.”
RxCost is Advera Health’s pioneering cost algorithm that calculates downstream direct medical costs associated with AE/drug combinations. This enables our clients not only to associate a cost to the labeled AEs, but more importantly to identify the unforeseen medical costs linked to serious non-labeled AEs and to make formulary/prescription changes as a result. The RxCost represents medical expenditures associated with the management of serious AEs experienced in the real world during a drug’s post-marketing phase. Simply put, it demonstrates which drug costs more from time of prescription through its lifespan with a patient.
Using RxCost and prescription data obtained by our partner, The Evaluate Group, we can estimate that if all Viekira Pak patients were instead given Harvoni, the healthcare system would have saved $3.7 million in downstream medical costs that result from Viekira Pak adverse events (AEs). And this is a conservative estimate. According to further Advera Health research, it is estimated that serious AEs are underreported for Harvoni and Viekira Pak by a factor of 1.77. Using this multiplier, the savings would top $6.5 million. We expect this expense to continue to grow as time goes on, and as more patients are given Viekira Pak.
So were the payers who chose Viekira Pak wrong? These data suggest they were. Did they choose short term financial incentives over long term costs and more importantly patient safety? It seems to be so. Should patients, prescribers, insurers and government agencies care? Without a doubt. Can a positive impact be made both in terms of costs and outcomes be made by reacting to these data? Definitely.
It is not a question of whether costs are out of control in healthcare, it’s a given, but what should also be a given is that data are data, it reveals the truth in numbers. And the numbers say patients with Hepatitis C should be provided with Harvoni over Viekira Pak, if safety is at all a factor.
Payers are highly focused on immediate cost containment rather than the longer-view approach that emphasizes outcomes and lowering total costs. And without a doubt we have proven with these data what a costly mistake this approach is.
Executive Vice President